The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Innovance Antithrombin With Models Opfh03, Opfho5.
| Device ID | K081769 |
| 510k Number | K081769 |
| Device Name: | INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 |
| Classification | Antithrombin Iii Quantitation |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE M/S 514 Newark, DE 19702 |
| Contact | Radames Riesgo |
| Correspondent | Radames Riesgo SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE M/S 514 Newark, DE 19702 |
| Product Code | JBQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-23 |
| Decision Date | 2009-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768027024 | K081769 | 000 |
| 00842768027017 | K081769 | 000 |
| 00842768037146 | K081769 | 000 |
| 00630414639796 | K081769 | 000 |
| 00630414639680 | K081769 | 000 |
| 00630414639673 | K081769 | 000 |